BioPharma Drug Approval
FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatec...
January 30, 2024 | News
OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell's proprietary platforms including Ori®Ab...
January 30, 2024 | News
This application is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), a Phase III trial to evaluate e...
January 29, 2024 | News
These were from a relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation, an alternative to the amorp...
January 29, 2024 | News
Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improv...
January 26, 2024 | News
GC1130A has previously achieved notable milestones by securing both Rare Pediatric Disease designation (RPDD) and Orphan Drug Designation (ODD) from the U....
January 24, 2024 | News
This achievement follows the recent confirmation from the Data Safety Review Committee that ISLA-101 has been deemed safe and well-tolerated in the 16 subj...
January 23, 2024 | News
AREXVY has been approved by the Therapeutic Goods Administration (TGA) for Australians 60 and over to protect against lower airway infection caused by re...
January 19, 2024 | Regulatory
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignan...
January 16, 2024 | News
Relivion® is a novel, non-invasive multi-channel brain neuromodulation technology. It stands out by concurrently stimulating the occipital and tri...
January 12, 2024 | News
First clinical trial to evaluate the safety and efficacy of OBI-992 (a.k.a BSI-992), a novel antibody drug conjugate (ADC) targeting TROP2 - Dosing of f...
January 09, 2024 | News
Dercum's disease is a rare disease characterized by the growth of painful lipomas. The pain can be severe, chronic (> 3 months) and often disabling. So ...
January 09, 2024 | News
This will be the second indication for which cadonilimab has received approval in China, following its use as a monotherapy treatment for recurrent or...
January 08, 2024 | News
-Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its marketing authorization application for t...
January 03, 2024 | News
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